FDA.reportPublic FDA data

Application 208249

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINTABLET;ORALEQ 500MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4528Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4528Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4528Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4606Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4606Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4606Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4700Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4700Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50268-076Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
50268-076Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
50268-076Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
51224-122Azithromycin DihydrateAzithromycin DihydrateTAGI Pharma, Inc.ANDACurrent
51224-122Azithromycin DihydrateAzithromycin DihydrateTAGI Pharma, Inc.ANDACurrent
53002-0474Azithromycin DihydrateAzithromycin DihydrateRPK Pharmaceuticals, Inc.ANDACurrent
53002-7221Azithromycin DihydrateAzithromycin DihydrateRPK Pharmaceuticals, Inc.ANDACurrent
55700-896Azithromycin DihydrateAzithromycin DihydrateQuality Care Products, LLCANDACurrent
68071-2775Azithromycin DihydrateAzithromycin DihydrateNuCare Pharmceuticals,Inc.ANDACurrent
68071-2775Azithromycin DihydrateAzithromycin DihydrateNuCare Pharmceuticals,Inc.ANDACurrent
68788-8311Azithromycin DihydrateAzithromycin DihydratePreferred Pharmaceuticals Inc.ANDACurrent
70518-3168Azithromycin DihydrateAzithromycin DihydrateREMEDYREPACK INC.ANDACurrent
70518-3168Azithromycin DihydrateAzithromycin DihydrateREMEDYREPACK INC.ANDACurrent
70518-3168Azithromycin DihydrateAzithromycin DihydrateREMEDYREPACK INC.ANDACurrent
71205-491Azithromycin DihydrateAzithromycin DihydrateProficient Rx LPANDACurrent
72189-090AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXANDACurrent
72189-090AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXANDACurrent
72789-063Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-063Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-063Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-066Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-169Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-169Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-169Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
80425-0220Azithromycin DihydrateAzithromycin DihydrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent